Condition category
Urological and Genital Diseases
Date applied
27/08/2019
Date assigned
05/09/2019
Last edited
05/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The MultICath trial is about finding out whether people who use intermittent catheterisation (IC) to empty their bladder experience no more urinary tract infections reusing some of their catheters than they would using their standard care single-use catheters.
Intermittent catheterisation is commonly used by people who have difficulty emptying their bladder because of bladder muscle weakness or nerve diseases. Intermittent catheterisation is generally a very useful way to empty the bladder as it avoids having to have a catheter in all the time and protects the bladder and kidneys from further damage.

Who can participate?
People over the age of 18 who are currently carrying out intermittent catheterisation.

What does the study involve?
We hope to recruit 520 participants. 50% of these participants will be randomised to using single-use catheters (usual care) with the other half randomised to the mixed-use strategy whereby participants will use a combination of single-use and multi-use catheters for 12 months. Participants in the mixed-use arm will use a reusable silicone catheter which CE marked for reuse for some of their intermittent catheterisation.

Participants who consent and are randomised to the trial will be asked to complete a series of questionnaires about their catheter use and any urinary tract infections (UTIs) experienced over the course of the trial in addition to their general health. Participants will also be required to provide regular urine specimens at specific time points and anytime the participant suspects a UTI.

What are the possible benefits and risks of participating?
By taking part, participants will be helping researchers to gather information and improve their understanding about intermittent catheterisation with multi-use catheters. Participants will be under closer follow-up than usual and may learn more about intermittent catheterisation from the information will give you during the trial.
It is possible that participants might experience a UTI, but this is a risk with all catheter use. There is not enough research evidence at the moment to be sure that the infection risk from multi-use catheters is not worse than single-use catheters and that is why we are doing the trial.
Some participants allocated to mixed-use catheter management might experience some discomfort or skin soreness when testing Cliny catheters, which is also a risk with all catheter use. Researchers will be gathering participants feedback about this throughout the trial.

Where is the study run from?
University fo Southampton, UK

When is the study starting and how long is it expected to run for?
November 2019 to November 2022

Who is funding the study?
The study has been funded with an NIHR Programme Grant for Applied Research.

Who is the main contact?
Prof. Mandy Fader
m.fader@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mandy Fader

ORCID ID

Contact details

Health Sciences
Building 67 Highfield Campus
University of Southampton
Southampton
SO17 1BJ
United Kingdom
+442380 596677
m.fader@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 42679

Study information

Scientific title

A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months

Acronym

MultICath

Study hypothesis

The use of a combination of single-use and multi-use catheters for participants carrying out intermittent catheterisation is no worse than in terms of the incidence of UTIs if only single-use catheters were used

Ethics approval

Approved 12/07/2019, South Central - Hampshire A Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8004; nrescommittee.southcentral-hampshirea@nhs.net), ref: 19/SC/0334

Study design

Randomised; Both; Design type: Treatment, Device, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urinary tract infection

Intervention

The researchers hope to recruit 520 participants who are carrying out intermittent catheterisation from around the UK. 50% of these participants will be randomised to using single-use catheters (usual care) with the other half randomised to the mixed-use strategy whereby participants will use a combination of single-use and multi-use catheters for 12 months. Participants in the mixed-use arm will use a reusable silicone catheter which CE marked for reuse for some of their intermittent catheterisation. ). Randomisation will be administered centrally by a secure web-based randomisation system. Permuted random blocks of variable length will be used to allocate participants 1:1 to the mixed-use and single-use only groups.

Participants who consent and are randomised to the trial will be asked to complete a series of questionnaires about their catheter use and any urinary tract infections (UTIs) experienced over the course of the trial in addition to their general health. Participants will also be required to provide regular urine specimens at specific time points and anytime the participant suspects a UTI.

Schedule of Events
Visit 1- Screening and baseline (face to face visit):
- Written informed consent from participant taken by appropriately delegated member of the research team.
- Eligibility confirmed and documented.
- Baseline activities completed- patient medical history taken, concomitant medication, baseline and randomisation CRF completed, Barthel index calculated and EQ-5D-5L completed.
-Urine sample taken and sent to central laboratory
- Participant randomisation to single-use IC or mixed-use IC strategy.

Two week learning period:
Participants in both the single-use and mixed-use IC strategy will participate in two week learning period.
For participants randomised to the mixed-us strategy, participants will be provided Cliny catheters and cleaning items and taught how to use the multi-use Cliny catheters.

Two week learning period (both arms)
- provision of event diary
-provision of catheter use 7 day diary
- AE/SAE assessment by research team
(Participants to complete diaries as an aide-memoire during two week learning period).

Monthly contact (telephone follow up from up to 12 months)
- Completion of monthly questionnaire with participant by research team.
- AE/SAE check by research team.
- Participant completion of 7-day catheter use diary and event diary
-Assessment of compliance (mixed-use arm only)
- As required, provision of Cliny catheters and products required for re-use (mixed-use arm only)

6-Month contact
In addition to the monthly questionnaire, AE/SAE assessment, assessment of compliance, the 6 month visit will
require completion of the following:
- 6 month questionnaire with participant by research team. 6 month questionnaire consists of the Intermittent Self-Catheterization Questionnaire (ISC-Q) and questions around patient costs.
- Health utilisation questionnaire
- EQ-5D-5L questionnaire
-Urine sample taken and sent to central laboratory

12-Month contact (EoS visit)
In addition to the monthly questionnaire, AE/SAE assessment and assessment of compliance, the EoS visit will also consist of completion of the following:
-EoS questionnaire with participant by research team. EoS questionnaire consists of the Intermittent Self-Catheterization Questionnaire (ISC-Q) and questions around patient costs.
- Health utilisation questionnaire
- EQ-5D-5L questionnaire
-Urine sample taken and sent to central laboratory
-Participants to return remaining Cliny catheters and unwanted products used for reuse to research team (mixed-use arm only).

At the time of UTI event, participant to complete and return:
- Urine sample (sent to central laboratory)
- UTI questionnaire (sent to Newcastle Trials Unit)

Optional: Semi-structured interview
Up to 40 participants from the mixed-use IC strategy will be approached to consent and participate in a semistructured qualitative interview.

Intervention type

Other

Phase

Drug names

Primary outcome measure

At least one episode over the 12 month follow-up period of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking behaviour (MC S UTI + H) defined as
- Presence of at least one sign or symptom (S; new or worsening; listed on the trial symptom set or other symptoms reported by the participant)AND
- Help-seeking behaviour (i.e. participant seeks help and/or treatment from GP/research nurse or other HCP or implements own self-help strategy e.g. increase fluid intake, self-administration of antibiotics)
AND
- 103 colony-forming units (cfu)/mL of ⩾1 bacterial species in a single catheter urine specimen taken within the previous 48 h and taken during a symptomatic episode before or after starting antibiotic treatment.

Secondary outcome measures

1. The number of MC SH-UTI over the 12 month follow-up measured as an incidence rate
2. At least one episode over the 6 month follow-up period of microbiologically confirmed symptomatic urinary tract infection with help-seeking behaviour (MC S-H UTI) as defined for the primary outcome
3. The number of MC SH-UTI over the first 6 months of follow-up measured as an incidence rate
4. Antibiotic use: Rate per month of prescription of antibiotics for presumed S-UTI (with or without meeting MC S-H UTI definition above) during the 12 month period as reported by the monthly questionnaire. This will also be examined over the first 6 months of follow up
5. Haematuria: Rate per month and proportion of 6-monthly urine samples meeting criteria of micro haematuria defined as > 40 RBC s/Ml as reported from routine urine sample during the 12-month follow-up. This will also be examined over the first 6 months of follow-up
6. Urethral bleeding: Rate per month of visible urethral bleeding during 12 month follow-up period as reported via monthly questionnaire. This will also be examined over the first 6 months of follow-up
7. User quality of life (QoL): QoL recorded by ISC-Q (Pinder tool) at 6-months and 12 months. The Pinder tool reports on single-use catheter only. A modified version for reporting on multi-use catheters will be used for mixed-use strategy. A weighted average of the two score completions will be used for the intervention (mixed-use) group: the weights will reflect the proportion of time catheters were used as single and multi-use
8. Health status recorded by the EQ-5D-5L questionnaire at baseline, 3-months, 6-months and 12-months
9. Proportion of participants expressing preference for one or other catheter management strategy (mixed or single-use only) in the intervention arm at 6 months and 12 months as measured by the 6 month and End of study (EoS) questionnaire
10. Costs of managing multi-use catheters versus single-use only. Measured by prescription of catheters, support and training received for the mixed package vs single-use catheters assessed using the unit costs for NHS resources based on representative national sources (NHS reference costs, units cost of Health and Social Care, 2003, Lesley Curtis)
11. To determine if a strategy of intermittent urinary catheter mixed-use is no worse than a strategy of intermittent urinary catheter single-use for outcomes of cost-effectiveness. Measured by UTI, monthly and health service utilisation questionnaire. Participants’ use of health care services related to IC, and S-UTIs will be based on self-reporting via the UTI questionnaire completed whenever a UTI is suspected and also during the monthly telephone follow-ups. Treatment costs will be based on the number of health professional consultations, tests and prescriptions recorded

Overall trial start date

01/01/2018

Overall trial end date

14/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult men and women aged > = 18 years
2. Currently using IC (via the urethra), performed by self or sole carer
3. Patients who have been IC users for at least > = six weeks
4. Patients where IC planned to continue for > 12 months and two weeks
5. Able and willing to adhere to a 12‐month follow up period
6. Patient has provided written informed consent for participation in the trial prior to any trial specific procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 520; UK Sample Size: 520

Participant exclusion criteria

1. Age < 18 years
2. Use of IC for self- dilatation of urethral stricture without bladder drainage
3. Non-urethral route for catheterisation e.g. Mitrofanoff
4. External, non-sole carer required for IC (i.e. where sterile technique and catheter is required e.g. visiting community nurse performs IC)
5. Inability to give informed consent or have primary outcome information collected
6. Employee or relation of employee of a manufacturer or distributor of IC catheters
7. Women who report they are pregnant or who plan to become pregnant during the trial
8. Participation in another trial
9. Patients in the terminal stage of an illness

Recruitment start date

15/11/2019

Recruitment end date

15/09/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Health Sciences Building 57 University Road
Southampton
SO17 1BJ
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

The Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Research Integrity and Governance Office
University of Southampton
Building 28
Room 2029
University Road
Southampton
SO17 1BJ
United Kingdom
+442380592517
A.Knight@soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0610-10078

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers plan to publish the study results in peer reviewed journal after the trial ends. The researchers also plan to publish a protocol paper

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/11/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/08/2019: Trial's existence confirmed by the NIHR.